Allergan Loses $212 Million Federal Botox Lawsuit in Virginia

By Margaret Cronin Fisk -
Apr 28, 2011

Allergan Inc. (AGN) was ordered by a
Virginia jury to pay $212 million to a 67-year-old man who said
he got permanent brain damage after being injected with Botox to
treat cramps and tremors in his hand in 2007.

The Richmond federal jury today awarded Douglas M. Ray
$12 million in compensatory damages and $200 million in punitive
damages, according to a verdict form provided by the court. Ray,
of Fredericksburg, Virginia, said Allergan failed to warn him
that injections could trigger an autoimmune reaction leading to
brain damage. Botox use left him disabled, Ray said.

Allergan denied a failure to warn or any connection between
Ray’s illness and Botox use. The company hasn’t decided whether
to appeal, said Caroline Van Hove, a spokeswoman for Irvine,
California-based Allergan.

“The verdict reached today is inconsistent with Allergan’s
past and current actions to properly warn physicians and
patients about the potential risks of Botox,” Van Hove said in
an e-mail. “Every known and knowable risk associated with Botox
treatment based on the scientific properties of the drug was in
fact warned about.”

Botox, used as a wrinkle smoother, is a purified form of
the poison botulinum and is given as an injection. It also won
regulatory approval last October for use as a treatment for
chronic migraine headaches. The drug is also approved to treat
“muscle stiffness” in the fingers and arms and “upper limb”
spasticity.

Botox is Allergan’s top-selling drug, with $1.42 billion in
sales last year, or 29 percent of the drugmaker’s revenue,
according to data collected by Bloomberg.

Damages Capped

The $200 million in punitive damages will be capped at
$350,000 under Virginia law, Van Hove said.

“If they appeal, we’ll attack the constitutionality of the
cap,” said Ray’s attorney, Ray Chester, in an interview.

Ray, a retired AT&T engineer who owned a custom hat design
business with his wife, received Botox injections in 2007 for
tremors and writer’s cramp in his right hand, according to the
complaint.

“Botox can migrate outside the injected muscles and cause
side effects including botulism and severe autoimmune reactions
with resulting brain damage,” Ray said in the complaint.

The injections left him “frequently confused or
disoriented” and unable to care for himself, he said. Allergan
was aware of this side effect and failed to sufficiently warn
doctors or patients to avoid losing sales, Chester said.

The case is Ray v. Allergan Inc., 3:10-cv-00136, U.S.
District Court, Eastern District of Virginia (Richmond).